WASHINGTON, D.C.—In the case that has become generallyfamiliar within the pharma/biotech community, the U.S. Supreme Court heardarguments last month seeking to invalidate Myriad Genetics' patents on two BRCAgenes associated with hereditary breast and ovarian cancer.
After previously having been set aside by a district court,the patents were upheld by the Federal Circuit Court, both initially and afterremand for reconsideration by the Supreme Court, which then agreed to take upthe case itself.
The lawsuit was filed by the American Civil Liberties Union(ACLU) and the Public Patent Foundation (PUBPAT) on behalf of a long list ofresearchers, patients, breast cancer and women's health groups and medicalprofessional associations.
While patent attorneys we spoke with were uniformly cautiousabout reading too much into the tea leaves based on oral arguments, they allexpressed doubt that, having taken up the case, the court would reaffirm theFederal Circuit Court's twice-articulated decision. Instead, the best bet seemsto be a sort of triangulation reminiscent of the Clinton Administration, wherethe court will come down on the side of a "third way" close to the positionarticulated by the Obama administration's solicitor general.
According to a summary by Morrison & Foerster's patentlawyers, the solicitor general's "amicusbrief on behalf of the United States, nominally supporting neither party, but …in practical terms, is seen as supporting the challengers." In a departure fromthe position of the Patent Office, the Solicitor General argues that "isolatedbut otherwise unmodified DNA is not patent-eligible."
According to the Solicitor General, the "public's ability tostudy and use native DNA would be unduly compromised if changes caused by theextraction of naturally occurring substances from their native environmentswere sufficient to trigger patent eligibility." The Solicitor General departsfrom the challengers when it comes to "complementary DNA" molecules, which thegovernment describes as "synthetic molecules built by scientists to include, ina single contiguous DNA segment, only the exons of a naturally occurring gene,without the introns and regulatory regions that are normally interspersed withexon sequences in genomic DNA."
Kevin E. Noonan, a biotechnology patent lawyer and partnerwith McDonnell Boehnen Hulbert & Berghoff LLP in Chicago, also thinks thecourt may take the advice of the solicitor general, one reason being that thecourt might be reticent to make a more sweeping decision because the justicesseem to appreciate that they lack a detailed understanding of the science atissue. Noonan also points out that the BRCA genes are something of a specialcase in terms of their impact on cancer rates. In breast cancer, for example, asingle BRCA mutation drives the cancer rate from 9 percent to 90 percent. Moretypically, a half-dozen or more mutations are involved.
"Unlike BRCA, if the genetic profile is complicated enough,"he says, "the inventor can decide not to disclose the pattern of mutations,hide it on a gene chip and make it very difficult to reverse engineer.Currently, universities do the work and get the patents. This might tip thescale to companies doing their own development and patent filings. A LabCorp orQuest could examine 100,000 samples of stomach cancer cells, determine what'sdifferent and what they have in common, then develop the test on a gene chip,encrypted, with false negatives and positives."
Jennifer A. Camacho, a patent attorney and shareholder at GreenbergTraurig LLP in Boston, finds it interesting that oral arguments did not includemuch discussion of Mayo vs. Prometheus, acase in which Prometheus' patents were invalidated amidst much concern for whatthis decision implied for the development of personalized medicine based onpatented diagnostic tests. She thinks this may be another indication that thistime, the Supreme Court will decide as narrowly as they must to answer thequestion, perhaps focusing on the wording of the claim or the DNA in someversion of the solicitor general's amicusbrief.